Regulatory Affairs

As FY 2014 draws to a close, the Office of Generic Drugs (OGD) has approved 45 ANDAs in August, the highest number for any month in this fiscal year, and through August 31 OGD has approved a total of 361 ANDAS thus far for this FY. In a repeat performance from last month, OGD reported receiving only 4 original ANDAs. Looks like firms are waiting for the October 1 to submit their ANDAs as the GDUFA metrics begin being applied to the cohort year 3 submissions.

As part of its GDUFA commitments the FDA has issued a Draft Guidance entitled Guidance for Industry – Controlled Correspondence Related to Generic Drug Development. FDA makes clear in this document that controlled correspondence (CC) does not include Citizen Petitions, petitions for reconsideration or stay requests.

The FDA’s paragraph IV (PIV) database is designed to give applicants and potential applicants information relative to first-to-file opportunities. FDA does this for two reasons: 1) it gives applicants assurance that their product is a first-to-file if the acknowledgement date (date acceptable for filing) on their letter from FDA officially receiving their application matches the date of submission in the PIV database. This has eliminated the many calls to the Office of Generic Drugs (OGD) to find out if their submitted application holds a potential first-to-file seat; 2) the listing also informs potential applicants that at least one ANDA has been submitted with a PIV certification and allows others to decide if they wish to enter the fray and expose themselves to litigation.

Over the last few days, FDA has posted information on new and updated drug shortages with 6 new shortages listed over the last week. We have noted the problems that drug shortages create in previous posts and we have all followed the media accounts of the problem; however, it still seems that, while many of the causes of drug shortages have been identified, stopping them from happening in the first place appears to be more elusive than any regulation, required notification or interaction with regulatory bodies can resolve.

With what seemed like the entire industry trying to beat the June 20, 2014 submission deadline ahead of the ANDA new stability requirements set to take effect that day, a record of 635 ANDAs were submitted in June. Now it looks like there will be some reload time before OGD sees the normal flow of ANDAs coming in.

Having heard about an important announcement made by OGD last week, I was fortunate enough to receive a copy of an internal email issued by Cook from the CDER trade press office. I read it once, and then reread it about 5 more times. “More changes at OGD” was the bottom line message, and then a question popped into my head. Is this message good news? If it results in more consistent actions coming out of OGD quicker, the answer is yes!